What SSI Duration is Most Effective? An Online Experiment With American Adults

NCT06313736 | Completed

• 2 other identifiers: STU00220591_shortening2T32MH115882-06A1
• Study Type: interventional
• Target: 1,145
• Locations: 1 country
• Sites: 1

Brief Summary

In a previous study (https://osf.io/qdznc), the research team found that an 8-minute version of a single-session intervention for loneliness was more effective than a 23-minute version of it. The present work aims to further explore the relationship between intervention duration and effectiveness. In this online trial, participants will be randomized to a 15-minute single-session depression intervention called the Action Brings Change (ABC) Program, a 10-minute version of it, a 6-minute version of it, or a 2-minute version of it. The main analysis will evaluate how change in depressive symptoms over eight weeks differs across conditions.

Conditions

Depression

Keywords

Single-session intervention; Length; Duration; Effectiveness; Active elements

Outcome Measures

Primary Outcomes (1)

• Change in Patient Health Questionnaire-8 at 8 weeks (PHQ-8; Kroenke et al., 2009)

  Patient Health Questionnaire-8 is a well-validated and self-administered measure to assess depression symptom severity in the general population. Participants are asked to rate how often they are bothered by 8 items (e.g., Poor appetite or overeating) on a scale of 0 (Not at all) to 3 (Nearly every day). Total score can range from 0 to 24, with higher scores indicating higher symptom severity.

  Baseline to 8 weeks post-intervention

Secondary Outcomes (12)

• Change in Beck Hopelessness Scale at 8 weeks (BHS-4; Perczel Forintos et al., 2013)

  Baseline to 8 weeks post-intervention

• Change in Beck Hopelessness Scale - 4-item at post-intervention

  Baseline to immediately post-intervention

• Change in UCLA Loneliness Scale 3-item version at 8-week follow-up (ULS-3; Hughes et al., 2004)

  Baseline to 8 weeks post-intervention

• Presence of an "Aha! moment" at post-intervention

  Immediately post-intervention

• Presence of an "Aha! moment" at 8 weeks post-intervention

  8 weeks post-intervention

Study Arms (4)

15-minute single-session depression intervention

EXPERIMENTAL

This is the adult version of the Action Brings Change (ABC) Project.

Behavioral: Action Brings Change Project (15-minute adult version)

10-minute single-session depression intervention

EXPERIMENTAL

This includes a shortened version of the ABC Project.

Behavioral: Action Brings Change Project (10-minute adult version)

6-minute single-session depression intervention

EXPERIMENTAL

This includes a shortened version of the ABC Project.

Behavioral: Action Brings Change Project (6-minute adult version)

2-minute single-session depression intervention

EXPERIMENTAL

This includes a shortened version of the ABC Project.

Behavioral: Action Brings Change Project (2-minute adult version)

Interventions

Action Brings Change Project (15-minute adult version) BEHAVIORAL

The ABC Project is a self-guided online single-session intervention based on principles of behavioral activation. In a slightly different form intended for adolescents, it has demonstrated efficacy in several studies. Its adult version has also shown some efficacy.

Also known as: ABC Project (15-min)

15-minute single-session depression intervention

Action Brings Change Project (10-minute adult version) BEHAVIORAL

This is a 10-minute shortened version of the 15-minute adult version of the ABC Project. The research team created it and pilot-tested it.

Also known as: ABC Project (10-min)

10-minute single-session depression intervention

Action Brings Change Project (6-minute adult version) BEHAVIORAL

This is a 6-minute shortened version of the 15-minute adult version of the ABC Project. The research team created it and pilot-tested it.

Also known as: ABC Project (6-min)

6-minute single-session depression intervention

Action Brings Change Project (2-minute adult version) BEHAVIORAL

This is a 2-minute shortened version of the 15-minute adult version of the ABC Project. The research team created it and pilot-tested it.

Also known as: ABC Project (2-min)

2-minute single-session depression intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Located in the United States
• At least 18 years old
• Patient Health Questionnaire-8 (PHQ-8) score of at least 10 (moderate or more severe) at screener.
• Able to read and speak fluent English
• Able to access to the internet via a computer, tablet or smartphone for the next eight weeks

You may not qualify if:

• Participants who have completed the first session of the study before or completed another study testing a depression intervention from our laboratory via the same participant recruitment platform in the past two months.

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Northwestern University Medical Social Sciences

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• Schleider JL, Mullarkey MC, Fox KR, Dobias ML, Shroff A, Hart EA, Roulston CA. A randomized trial of online single-session interventions for adolescent depression during COVID-19. Nat Hum Behav. 2022 Feb;6(2):258-268. doi: 10.1038/s41562-021-01235-0. Epub 2021 Dec 9.

  PMID: 34887544 BACKGROUND

• Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.

  PMID: 18752852 BACKGROUND

• Perczel Forintos D, Rozsa S, Pilling J, Kopp M. Proposal for a short version of the Beck Hopelessness Scale based on a national representative survey in Hungary. Community Ment Health J. 2013 Dec;49(6):822-30. doi: 10.1007/s10597-013-9619-1. Epub 2013 Jun 12.

  PMID: 23756722 BACKGROUND

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

  PMID: 11132119 BACKGROUND

• Terides MD, Dear BF, Karin E, Jones MP, Gandy M, Fogliati VJ, Kayrouz R, Staples LG, Titov N. The frequency of actions and thoughts scale: development and psychometric validation of a measure of adaptive behaviours and cognitions. Cogn Behav Ther. 2016 Apr;45(3):196-216. doi: 10.1080/16506073.2016.1149876. Epub 2016 Feb 29.

  PMID: 26926484 BACKGROUND

• Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.

  PMID: 18504506 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jessica L Schleider, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. They will know that the study compares multiple interventions but will not know to which arm they have been assigned. Additionally, the measures will be self-administered, so there is no scope for evaluator bias. There will be no interaction between participants and investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be assigned to one of four different conditions.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 15, 2024
• Study Start: March 20, 2024
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Anonymized data and code will be made publicly available here (https://osf.io/g846j/) upon publication of trial results.
• Access Criteria: Publicly available

Locations

US (1)